Four-dimensional analysis system, apparatus, and method

ABSTRACT

A system for measuring fluid absorption and retention properties of various samples having one or more materials, layers and/or articles. The system includes an optically or radiographically transparent fixture. The system enables measuring voxels having a grayscale value that demonstrate a difference in fluid densities and thereby enable the study of fluid flow and movement within and/or amongst various materials and articles in real time.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation application of U.S. patentapplication Ser. No. 15/354,412, filed Nov. 16, 2017, claims the benefitof priority to U.S. Provisional Patent Application Ser. No. 62/256,405filed on Nov. 17, 2015, the contents of which are incorporated byreference herein.

BACKGROUND

Studies and research have been undertaken to determine the efficacy ofpersonal care products. For example, in the context of feminine hygieneproducts, research has been performed to determine the effectiveness ofthe products in absorbing fluid.

The quality of the results that are obtained in connection with theresearch are influenced by the quality of the test system, apparatus,and methodology that are used. For example, due to the complexity of theimaging technology (e.g., computed tomography (CT) scanning) that isused as well as variations in the products/samples that are beinganalyzed, it is difficult to determine a grayscale value that bestrepresent those volumetric pixels (voxels) of reconstructed data setsthat correspond to fluid entering a given sample. In the context ofmedical imaging. CT scans can be low resolution and fail to recreatereal-time conditions despite successive scans or a series of scans.Further still, in vivo set-ups can be costly and require significantamounts of time to, inter alia, organizing subject populations, creatinga test protocol, scheduling the scans and analyzing the results.Accordingly, there is uncertainty that is introduced that is difficult,if not impossible, to account for. Furthermore, due to delays betweenthe capturing of the image and when the associated data set becomesavailable, events such as an advancement of a fluid-front in associationwith the sample may be missed or unaccounted for.

SUMMARY OF THE PRESENT DISCLOSURE

The present disclosure provides a system for determining real-time fluiddynamics within or near a device. The system includes a fixture thatsimulates an in vivo set-up via at least one characteristic. The fixturesimulates bodily pressure exerted against a device. The device is aconsumer product such as a hygiene device, an implement, and/or amedical device. The device is an internally worn device or an externallyworn (or externally manipulated) device. In some embodiments, the deviceis dynamic in that it changes in shape, configuration and/or othermechanical properties upon implementation (i.e. upon contacting thebody, fluid and/or by its design). In some embodiments, the device isdynamic due to other forces exerted upon it. Such forces could bebodily, such as pressure exerted by the body cavity against aninternally worn device. Such forces could be from other objects, such asgarments worn adjacent the body, pressure exerted by a bed or a chairwhen a person is lying or sitting, and/or limbs directing the device'smovement and/or affecting the device's configuration.

The fixture is a somewhat simple structure as exemplified in FIGS. 1-4.The fixture accommodates a device (herein referred to as the “sample” or“test sample”).

The fixture is a more complex structure as shown in FIGS. 5-7. Suchfixtures include multiple regions that can be fixed and thus relativemovement amongst these regions is limited, or these regions can beseparate, attachable and/or movable with respect to each other to createa dynamic in vivo-esque profile.

The fixture is a further refined structure as shown in FIGS. 8a -8 c.Such fixtures are formed from human body scans or measurements, bothinternal and external. Such fixtures are static and/or dynamic (i.e. theone or more leg regions are able to move with respect to the torso orpelvic region)

The fixture is radiographically transparent or translucent(“radiotransparent”) such that a scanning means (such as CT or micro-CT)can be employed. Optionally, the fixture is visually transparent. Thefixture is attached to a platform that permits rotation about at leastone axis, thereby permitting imaging of the sample in real time. Thefixture can move about multiple axes to generate different views and/ordifferent configurations to replicate the position and functionality ofthe sample of the device in simulated conditions. Movement of a fixturein at least one direction, plane and/or along an axis other than togenerate an image, can be done with a cadence that simulates in vivointeraction and motion amongst body parts and the device.

BRIEF DESCRIPTION OF THE DRAWINGS

The present disclosure is illustrated by way of example and not limitedin the accompanying figures in which like reference numerals indicatesimilar elements.

FIG. 1 illustrates a diagrammatic representation of one embodiment ofthe present disclosure's test fixture apparatus.

FIG. 2 illustrates a diagrammatic representation of one embodiment ofthe present disclosure's test fixture apparatus.

FIG. 3 illustrates a diagrammatic representation of one embodiment ofthe present disclosure's test fixture apparatus.

FIG. 4 illustrates a diagrammatic representation of one embodiment ofthe present disclosure's test fixture apparatus.

FIG. 5 illustrates a diagrammatic representation of one embodiment ofthe present disclosure's test fixture apparatus.

FIG. 6 illustrates a diagrammatic representation of one embodiment ofthe present disclosure's test fixture apparatus.

FIG. 7 illustrates a diagrammatic representation of one embodiment ofthe present disclosure's test fixture apparatus.

FIG. 8a illustrates a diagrammatic representation of one embodiment ofthe present disclosure's test fixture apparatus.

FIG. 8b illustrates a diagrammatic representation of a back view of oneembodiment of the present disclosure's test fixture apparatus.

FIG. 8c illustrates a diagrammatic representation of a side view oneembodiment of the present disclosure's test fixture apparatus.

FIG. 9 illustrates a diagrammatic representation of a side view oneembodiment of the present disclosure's test fixture apparatus.

FIG. 10 illustrates a computing system architecture.

FIG. 11 illustrates a system that is configured to represent a fluid orfluid flow associated with a sample.

FIGS. 12A-12E illustrate a flow chart of an exemplary method forrepresenting a fluid or fluid flow associated with a sample.

FIG. 13 illustrates a fixture in accordance with aspects of thisdisclosure.

FIG. 14 illustrates a flow chart of an exemplary method for representinga fluid or fluid flow associated with a sample based on the use of areference.

DETAILED DESCRIPTION

It is noted that various connections are set forth between elements inthe following description and in the drawings (the contents of which areincluded in this disclosure by way of reference). It is noted that theseconnections are general and, unless specified otherwise, may be director indirect and that this specification is not intended to be limitingin this respect. A coupling between two or more entities may refer to adirect connection or an indirect connection. An indirect connection mayincorporate one or more intervening entities.

Aspects of the disclosure are directed to systems, apparatuses, andmethods for performing an analysis on one more samples. A sample 204 maybe associated with a device such as a personal care product, includinghygiene products, medical devices, including diapers and femininehygiene products worn internally and/or externally (e.g., a pledget, anapplicator, a menstrual cup, a napkin, a pad, a liner, a pessary, asuppository etc.) for menstrual and/or incontinence purposes. As forsuppositories, the disclosure demonstrates the dissolution and/ortransition of a suppository as it enters the body and chemicallyinteracts with the body, thereby inducing a change in the suppository'sstate or transport of the material contained within or delivered by thesuppository. In some embodiments, a fluid may be injected/introduced tothe sample 204, and an analysis may be performed todetermine/characterize how the fluid flows in/through the sample 204.For example, if a flow rate of fluid 246 introduced to the sample 204 isa constant, a grayscale value that best represents volumetric pixels(voxels) of a reconstructed data set that correspond to the fluid 246entering the sample 204 can be determined heuristically. As one skilledin the art would appreciate, a grayscale value may serve as arepresentation of an intensity, ranging from black to white, of a voxel.A voxel may be associated with a three-dimensional data structuredefined by a grayscale value, a length, a width, a height, and arelative position in space.

Referring now to FIG. 1, a fixture 202 is shown. The fixture 202, as atleast a part of system 200, may be used to represent/simulate a fluidflow associated with one or more samples 204.

The fixture 202 may be configured to retain a sample 204 (e.g., apersonal care product) that is to be subjected to an analysis inaccordance with aspects of the disclosure. The retention of the sample204 may be facilitated by the fixture 202 and/or use of retainingmechanism 206. The retaining mechanism 206 may be made of foam or othermaterial such as materials similar to garments, underwear and/or beds,chairs, etc. . . . . The retaining mechanism 206 may also have ahydrophobic layer or portion such as a plastic, film or silicone. Theretaining mechanism 206 may exhibit properties, such as pressure, thatsimulate properties of tissues such that the in vitro set-up mimics anin vivo set-up. The retaining mechanism 206 may include a bore 208 forholding the sample 204 that is in communication with a fluid line 211,particularly the fluid line end 211 a. In some embodiments, fixture 202is also a retaining mechanism 206. Bore 208 may be generally cylindricaland/or have an arcuate or varying geometry. In some embodiments, fixture202 has a recess 208 a that further assists in retaining sample 202.Recess 208 a is in concert with bore 208 and creates a slightly raisedlip such that sample 204 can be more easily positioned within oradjacent to fixture 202. Bore 208 can be positioned in varyingconfigurations and/or orientations within fixture 202 such that fluidflow can enter or surround sample 204 as per known gravitational forces.

Fixture 202 has an upper region 228 and a lower region 230, and as shownmore easily in FIG. 3, a middle region 229. As shown in FIGS. 1-4, theupper, lower and middle regions can have a variety of configurations andpurposes, depending on the set-up and predetermined goals of the study.Fixture 202 has a bore 208 and an opening 231. Bore 208 provides accessfor sample 204 and/or a line 211 transmitting fluid into, around orproximal to the sample 204. Opening 231 permits further access to theinterior volume 234 of fixture 202, permitting easier insertion and/orremoval of sample 204 and other items described throughout the presentdisclosure. To facilitate opening 231 and thusly access to the interiorvolume 234, fixture 202 has one or more hinges 236 that permit an arm238 of fixture 202 to deflect and/or move about a pivot point, axis,and/or plane. Said differently, arm 238 is hingedly connected to fixture202 about one or more hinges 236. Interior volume 234 is defined byinterior surface 235.

The bore 208 has a size similar to that of a predetermined sample 204.For instance, known tampons have a diameter of between about 0.48 inchesto about 0.63 inches (or about 12 mm to about 16 mm) and a length ofabout 1.25 to about 3 inches. Other known internally worn menstrualdevices such as cups have a diameter of about 1 inch while others have adiameter of up to 3 inches. As such, bore 208 is sized similarly tosamples 204 of these devices. Alternatively, bore 208 is sized toemulate the in vivo environment. By way of example, the bore 208 issuitably configured to receive an internally worn hygiene device, suchas a tampon, and as such, is sized and shaped similarly to any knownvaginal cavity anatomy and/or mean, median, mode or otherwiserepresentative dimensions.

FIGS. 1-4 exemplify a bore 208 generally disposed along the centralvertical 240 axis of fixture 202, but can be in other locationsdepending on the configuration of the fixture 202. For instance, FIGS.5-7 exemplify fixtures 202 having one or more contoured surfaces 281 andshapes more closely resembling at least one surface of the human body,more specifically, the pelvic region, and even more specifically,between the upper legs (or thighs), the vaginal, urethral, and/orbuttocks regions.

The bore 208 may be configured to have a size that corresponds to apredetermined pressure that is applied to the sample 204 by the fixture202. For example, bore 208 is configured to have a diameter 207 that isslightly smaller than the sample 204 of a device such as a tampon, suchthat a predetermined bodily pressure is exerted along at least a portionof the sample 204 (and in some embodiments, along the entire axiallength of the sample 204). For example, the fixture 202 applies at leastone of a hydraulic pressure or a pneumatic pressure to the sample 204.To apply such pressure, a wrapper 212 is provided proximal, adjacent toand/or surrounding the sample 204. The wrapper 212 is made of a materialhaving a low density that is sufficiently distinct from the fluid 246density and/or sample 204 density, to avoid any imaging confusion withsample 204. The wrapper 212 is often positioned in close proximity tosample 204, so it is critical the wrapper 212 is radiographicallydiscernable from the sample 204 and/or the fluid 246 contained withinthe wrapper 212. Such wrapper 212 materials include hydrophobic foams,closed cell foams, polyurethane, plastics, films and laminates,polyethylene, low density polyethylene, linear low density polyethylene,polyester, polypropylene, nylon and other long-chain carbon materials,etc. The system utilizes fluid of a predetermined viscosity. In someembodiments, the fluid has varying viscosity. In some embodiments, thefluid utilized to generate hydraulic or pneumatic pressure isnon-Newtonian. The application of the pressure to the sample 204 may bedone to simulate an application of bodily pressure to the sample 204when the sample 204 (or an analogous sample) is inserted in a bodycavity.

The pressure is preferably between about 0.1 psi to about 5 psi, andmore preferably between about 0.25 psi and 1 psi. Such pressure can beexerted by the fixture 202 in its entirety to simulate an overall bodilypressure. Alternatively [or additively], such pressure can be exerted bya single aspect or member of the fixture 202 to simulate certainanatomical features that exude pressure against a sample 204. Further,other pressures exerted by, for instance, involuntary or voluntarybodily reactions such as hiccups, sneezing, coughing, laughing, etc.,can also create dynamic pressure(s). For example, the fixture 202 mayprovide a pressure of about 0.25 psi to simulate pressure of the bodysurrounding the vaginal canal, but may have an additional member 209that adds an additional pressure simulating the pressure applied to thevaginal cavity by a full or partially full bladder. The additionalmember 209 in the fixture 202 can be located within and/or proximal thebore 208 such that it applies pressure directly to the sample 204 and/orindirectly to the sample 204. Additional member 209 can comprise abladder and contain fluid, and can be dynamic (i.e. fluid volume in thebladder increases or decreases). The pressure exerted by the additionalmember 209 can be dynamic alone or in concert with the fixture 202 (i.e.where the fixture 202 applies dynamic pressure). Dynamic pressure can bedescribed as pressure that changes over time. Dynamic pressure alsoincludes, in certain embodiments, the force exerted outwardly by aconsumer product as it absorbs and/or retains fluid (and thus expands orchanges in size/shape).

Additional member 209 provides fixture 202 the opportunity to have aplurality of different pressures exerted by multiple different objectsand/or fluids. For instance, a first pressure 209 a is exerted on thesample 204 by fixture 202. A second pressure 209 b is provided via fluiddisposed or dispensed into a wrapper 212 surrounding and/or proximal tothe sample 204 situated in or adjacent to the fixture 202 (i.e. in thebore 208 as shown in FIG. 3). A third pressure is provided viaadditional member 209 situated proximal the fixture 202 such that itexerts an additional force or pressure onto the fixture 202, causing thesimulation of another environmental variable. In this embodiment, thefixture 202 simulates general bodily pressure. The additional member 209simulates the environment of the vaginal canal. The additional member209 simulates the pressure exerted within the body against the vaginalcanal by the bladder.

In one embodiment, the fixture 202 permits expansion to accommodatestudies of dynamic systems. The fixture 202 permits expansion to, forinstance, permit a significant amount of pressure to be exerted (via theaccumulation of fluid 246 in the bladder of additional member 209) whilekeeping the bladder within the fixture 202 and proximal the sample 204.The fixture 202 can comprise a material that is expandable or extensibleor compressible such that it changes shape in response to the, forinstance, bladder's shape. In embodiments where the fixture 202 materialis compressible, it must remain radiotransparent upon compression.Advantageously, compressible structures can be structured to maintainthe general shape and size of the footprint to ensure the system 200isn't altered.

In embodiments where the fixture 202 is expandable or extensible, it canbe due to the material properties of the fixture 202 itself, and/or thephysical structure. For instance, and as exemplified in FIGS. 1 and 2,the fixture 202 can have arms 238 that deviate in position uponexpansion of the sample 204 and/or due to the expansion of additionalmember(s) 209.

In further embodiments, the fixture 202 has one or more retaining straps214. In a first embodiment, the one or more retaining straps 214 areextensible thereby permitting expansion/deflection after a certain levelof force is reached (i.e. a force exceeding the force exerted by theretaining strap(s) 214). This can be advantageous in set-ups wheredeflection is useful for inserting samples 204 into (or adjacent to, oronto the fixture 202) and/or modifying the fixture 202 to perform in acertain manner, while ensuring the fixture 202 remains substantiallystatic with respect to the platform 216 during the test.

In some embodiments, the one or more retaining straps 214 can bepositioned to provide pressure to the fixture 202 to simulate bodilypressures in addition to, in lieu of, or to support pressures exerted byother portions or structures of the fixture 202. The one or moreretaining strap 214 can be placed around a portion of the fixture 202 toexert a specific pressure around a portion of the length, width and/orheight of the sample 204. The one more retaining strap 214 can be placedaround a portion of the fixture 202 to exert a specific pressureadjacent a sample 204, such as proximal to the inferior sample 204 endand/or the superior sample 204 end, the sample forward end, the samplerearward end, etc. . . . . In these embodiments, a pressure adjacent thesample 204 can simulate the sample's 204 performance in vivo, modelingthe pressure applied by external anatomy such as limbs (i.e. arms orlegs), by internal anatomy such as the cervical os, the bladder, thevaginal wall, the introitus, and/or by garments such as underwear,pants, etc. . . . .

In a second embodiment, the one or more retaining strap 214 aresubstantially rigid. In this embodiment, the fixture 202 remainssubstantially static during the test, but permits access or modificationto the fixture 202 before and after the test.

The one or more retaining straps 214 can be a unitary structure such asan elastomeric band or tape. The one or more retaining straps 214 canalso have a clasp 213 permitting adjustment of the one or more retainingstraps 214 to modify pressure around at least a portion of fixture 204.The one or more retaining straps 214 can be attached and/or positionedon or surrounding a portion of fixture 204, or can be attached toplatform 216, or combinations thereof.

The fixture 202 may include a fluid source 210 that is configured tointroduce/apply a fluid 246 to the sample 204 by a line 211 coupling thefluid source 210 and the sample 204 in FIG. 7. Fluid source 210 isattachable to system 200, to fixture 202, and/or to platform 216. Thefluid 246 provided by the fluid source 210 may be of any type orcomposition, such as water, menses, blood, synthetic menses, glycerin,etc., or a mixture of one or more of the aforementioned fluids. In someembodiments, a dye may be used in the fluid 246. The fluid 246 may beselected to have a density that is sufficiently distinct from thedensity of the fixture 202 (in an amount greater than a threshold), suchthat the fluid 246 and the fixture 202 can be distinguished from oneanother via imaging technology. In some embodiments, the fluid 246density is significantly distinct from a density of the fixture 202. Insome embodiments, the fixture 202 may be clear/see-through/translucentto a user's naked eye (to facilitate a visual inspection of the sample204 when the sample is retained in the fixture 202), such that thefixture 202 may be optically transparent. However, in some embodimentsthe fixture 202 might only be radiographically transparent/translucent.

Starting with a dry sample 204, the fixture 202 may cause the fluidsource 210 to apply fluid 246 to the sample 204 until the sample 204 issaturated.

The fixture 202 may include a wrapper 212. The wrapper 212 may retainthe sample 204 in the bore 208 of the retaining mechanism 206. Thewrapper 212 encompasses at least a majority of an outer periphery ofsaid fixture 202. To the extent fluid 246 escapes the sample 204 and/oris meant to surround sample 204, the wrapper 212 may prevent fluid 246from the fluid source 210 leaking onto/into the retaining mechanism206/bore 208 by creating a barrier between the bore 208, the opening 231and/or the fixture 202 in general that substantially keeps fluid insidethe wrapper 212.

FIGS. 5-7 provide an additional aspect of the present disclosure, wherethe fixture 202 and/or retaining mechanism 206 are configured to morespecifically replicate an in vivo set-up. As shown in FIGS. 5-6, Fixture202 includes a first region 280, a second region 282, and a third region284. The first region 280, second region 282 and third region 284 can befixed and stationary (with respect to each other) or movable and dynamic(with respect to each other) The first region 280 and the third region284 support second region 282, and/or simulate a portion of the humanbody. First region 280 and second region 284 provide support for secondregion 282, and as such, resemble limbs such as legs in an in vivosetup. Second region 282 provides at contoured surface 281. Secondregion 282 has a contoured surface 281 emulating at least one surface ofan in vivo setup. First region 280 and/or third region 284 may also havecontoured surfaces to further simulate an in vivo setup.

FIG. 6 provides a retaining mechanism 206 holding sample 204 adjacentthe body. Retaining mechanism 206 optionally includes one or moreretaining straps 214 (and optionally one or more clasps 213). Barrier250 is adjacent retaining mechanism 206 on a surface facing fixture 202which is adjacent sample 204. Barrier 250 is integral with retainingmechanism 206 and/or attachable to retaining mechanism 206. Barrier 250optionally has varying surface topography to simulate vaginal rugaeand/or other anatomical features of the body.

FIG. 6 provides a bore 208 that is internal to fixture 202. In thisembodiment, bore 208 provides a means for retaining and/or directingline 208 (and line end 211 a) into a location that simulates the urethraor vaginal cavity. In such embodiments, line 208 and line end 211 a ispositioned with respect to sample 204 to simulate fluid flow in an invivo setup. In further embodiments, bore 208 extends through fixture 208such that line 208 runs internally through fixture 202; bore 208 has afirst opening (not shown) line 208 enters and a second opening 208 bwhere line end 211 a deposits fluid 246 onto or proximal to sample 204.In further embodiments, bore 208 simulates an internal body cavity suchas the vaginal cavity. In other embodiments, line 208 is positionedexternal to fixture 202 and attachable at least at a position similar towhere the urethra or vaginal opening would be in an in vivo setup suchthat fluid 246 exits line end 211 a at an appropriate location proximalto or on sample 204.

FIGS. 8a-8c provide various views of a fixture 202 emulating themidsection of a person. The description provided for FIGS. 5-7 alsoholds true with these embodiments exemplified by FIGS. 8a -8 c. Fixture202 has a first region 280, second region 282, and a third region 284.Fixture 202 replicates human body. Fixture 202 is, for example cut froma radiotransparent material such as foam by a CNC machine that hasinputted data from a human body scan. The CNC machine cuts individualslices of the radiotransparent material which are thereafter connectedby adhesive, one or more retaining straps, etc. . . . . The CNC machinecan optionally create bore 208 such that it also resembles the humanbody (i.e. the vaginal cavity). In this manner, fixture 202 can simulateboth internal and external human anatomy and thus fixture 202 providesthe opportunity to have an in vitro setup that even more closelyresembles an in vivo one.

Referring now to FIG. 10, an illustrative system 100 is shown. Thesystem 100 may be associated with one or more computers. The system 100includes one or more processors (generally shown by a processor 102) anda memory 104. The memory 104 may store data 106 and/or instructions 108.The system 100 may include a computer-readable medium (CRM) 110 that maystore some or all of the instructions 108. The CRM 110 may include atransitory and/or non-transitory computer-readable medium.

The instructions 108, when executed by the processor 102, may cause thesystem 100 (or one or more portions thereof) to perform one or moremethodological acts or processes, such as those described herein. As anexample, execution of the instructions 108 may cause: one or more imagesof a sample to be captured based on an introduction/application of afluid 246 to the sample 204, a data set to be obtained/generated basedon the one or more images, and an analysis to be performed based on thedata set to determine a grayscale value that represents a fluid 246flow.

The data 106 may include the images, the data set or additional databased on an analysis of the data. In some embodiments, the data 106 maybe associated with one or more programs, such as a modeling orsimulation program. For example, the data may be native to or supportedby one or more computed aided design or computer aided drawing programs,either one or both of which may be referred to as CAD programs.

The system 100 may include one or more input/output (I/O) devices 112that may be used to provide an interface between the system 100 and oneor more additional systems or components. The I/O devices 112 mayinclude one or more of a graphical user interface (GUI), a displayscreen, a touchscreen, a keyboard, a mouse, a joystick, a pushbutton, amicrophone, a speaker, a microphone, a transceiver, a sensor, etc.

The system 200 includes an imaging device 222. The imaging device 222may take/acquire one or more images of the sample 204, such as whenfluid 246 from the fluid source 210 is applied to the sample 204. Thefrequency with which the one or more images are taken can be dependenton the viscosity of the fluid 246 and/or the properties of the sample204. In other words, a fluid 246 having a higher viscosity may travelmore slowly through the sample 204, and as such, time between images maybe longer without missing meaningful data sets. Alternatively, a sample204 having greater porosity, permeability, wicking rates, etc. . . . mayrequire more frequent imaging to fully capture data sets that willdemonstrate fluid 246 movement within sample 204. In some embodiments,sample 204 has multiple different materials and/or rates and theconfiguration of such materials in sample 204 require varying rates withwhich images are taken. For instance, images may need to be taken morequickly as fluid 246 is introduced into a wicking layer or highlypermeable area of the sample 204, and thereafter, slower time intervalsfor taking images may be sufficient as the fluid 246 travels more slowlythrough less permeable absorbent areas of the sample 204. The skilledartisan understands that time intervals may vary more complexly thandescribed herein. In some embodiments, images are taken less than oneminute apart. In further embodiments, images are taken about ten tofifteen seconds apart. In further embodiments, images are taken lessthan ten seconds apart.

In some embodiments, the fixture 202 or a portion thereof (e.g., theretaining mechanism 206) may rotate in order to cause the sample 204 torotate. The rotation may occur at a predetermined rate. The rotation mayoccur when the images are acquired by the imaging device 222.Alternatively, or additionally, the imaging device 222 may rotaterelative to the fixture 202/sample 204. Relative rotation enablescapturing multiple views of the sample 204 during the test. In someembodiments, the fixture 202 is placed upon and/or attached to theplatform 216. The platform 216 is a rotatable surface 216 a (i.e. aturntable) in at least one plane (i.e., the x-y plane, the y-z plane,and/or the x-z plane) and/or optionally in at least two planes (i.e. ashaker table). In other embodiments, the fixture 202 is attached to agimbal 216 b, 216 c (as represented by both solid and dashed lines inFIG. 9) permitting dynamic movement in multiple planes or about multipleaxes. The platform 216 (i.e., rotatable surface 216 a or gimbal 216 b,216 c) assists the imaging device 222 in visually capturing the sample204's performance during the test.

As shown in FIG. 9, gimbal 216 b, 216 c has a first linkage 260, asecond linkage 262 and a third linkage 264, where the first linkage 260and second linkage 262 are connected and/or movable about each other atjoint 270. Second linkage 262 and third linkage 264 are connected and/ormovable about joint 272. Gimbal 216 b, 216 c is stabilized by base 266.Gimbal 216 b, 216 c is connected directly to base 266 or by shaft 268.The aforementioned configuration permits rotation amongst first linkage260 and second linkage 262, and second linkage 262 and third linkage264. In total, it permits angular rotation of platform 216 and thuslyfixture 202 and sample 204.

In some embodiments, a partial gimbal 216 b is provided to permitrelative rotation between the sample 204 that is proximal to the fixture202 (i.e., within or adjacent the fixture 202) and the imaging while notobstructing the imaging device 222 or any other features connected tothe fixture 202. A partial gimbal 216h is exemplified by the solid linesin FIG. 9. For instance, the partial gimbal provides three dimensionalrotation in a partial sphere such that other features can be positionedor connected to the test fixture 202 in areas where there is nomovement. Although rotation is restricted with a partial gimbal, itstill provides the ability to study the sample 204 in simulatedconditions (i.e. shifting of a sample 204 during a person's gait, thesample's 204 response to one or more dynamic bodily pressures, etc. . .. ). In some embodiments, the partial gimbal is a half gimbal. In otherembodiments, a full gimbal is provided (as indicated by the solid anddashed lines in FIG. 9).

In some embodiments, rotation about at least one axis simulates relativein vivo movement of a person and the device. For instance, and withrespect to products worn on or internally to the body during physicalmotion, a typical gait for a person is about three miles per hour. Assuch, depending on the size of the fixture 202, the fixture 202 rotatesabout at least one axis at rate of about 52 in/second. As peopletypically move at speeds between 0.1 mph and about 25 mph, the fixture202 is capable of rotating at speeds between about 1.7 in/second toabout 806 in/second, or perhaps more typical for most people partakingin exercise, speeds between about 52 in/second to about 176 in/second.

As shown in FIG. 7, dynamic pressure can be applied via additionalmembers 209 a and 209 b. Additional members 209 a, 209 b articulateabout joint 248 a, 248 b, respectively. Additional members are capableof applying a static pressure as well. Additional members 209 a, 209 bapply pressure in at least one plane, or by articulating about at leastone axis. Such articulation can work in concert with the movement offixture 202 or retaining mechanism 206 on platform 216. For instance,additional members 209 a and 209 b can simulate rubbing amongst bodyparts such as limbs and the torso, or more specifically, the legs andthe pelvic region, while a sample is being worn externally as shown inFIG. 7 (or internally as demonstrated throughout the specification).Movement of additional members 209 a, 209 b can be done to simulatebodily pressures exerted amongst body parts at a rate similar to that ofa person walking, running, or participating in athletics, as describedin the present disclosure. In certain embodiments, barrier 250 separatesthe retaining mechanism 206 (or fixture 202, in other embodiments) andsample 204 such that any fluid 246 escaping the sample 204 does notsaturate and/or soil retaining mechanism 206 (or fixture 202). Thissimplifies cleaning and maintenance. As such, barrier 250 is animpermeable material that is preferably radiotransparent, or at the veryleast, has a density sufficiently distinct from the sample 204 and/orfluid 246. Some examples of materials include silicon and other plasticsand foams mentioned throughout the present disclosure. Such a barrier250 can be applied to any of the exemplary fixtures of the presentdisclosure.

A modified syngyna test methodology can be used in ascertaining fluidhandling performance and absorbent characteristics of the sample 204.Such a set-up includes a syringe pump 220 moving fluid 246 from a fluidsource 210 such as a beaker, hag and/or graduated cylinder, to a line211 located proximal to the sample. The line 211 has a line end portion211 a that dispenses (i.e. drips) fluid 246 at a predetermined ratecontrolled by the syringe pump 220. The components of the line 211 andline end portion 211 a must be material that will not disrupt theimaging and as such, should be made from a material that is sufficientlydistinct from sample 204 and/or fluid 246. Preferably, the line and endportion are radio transparent. For instance, the rate is between about10 ml/hr to about 70 ml/hr, or more preferably, between about 20 ml/hrto about 50 ml/hr, or even more preferably, about 25 ml/hr forinternally worn menstrual products and about 50 ml/hr for externallyworn hygiene products such as menstrual or incontinence underwear,diapers, napkins, pads, and/or liners.

The imaging device 222 may be operative in accordance with one or moreimaging technologies. For example, the imaging device 222 may beoperative in accordance with at least one of computed tomography,magnetic resonance imaging, nuclear magnetic resonance imaging, ormagnetic resonance tomography. In some embodiments, the imaging device222 may include an imaging source 224 and an imaging detector 226. Theimaging source 224 and the imaging detector 226 may be operative inaccordance with x-ray technology.

The system 200 includes a computer 232. The computer 232, which mayinclude one or more of the components/devices described above inconnection with the system 100 of FIG. 10, may be configured tocoordinate or synchronize the activities of the fixture 202 and theimaging device 222. The computer 232 may also perform one or more of themethodological acts described herein. For example, the computer 232 mayobtain one or more images from the imaging device 222, obtain one ormore data sets based on the images, and perform an analysis inconnection with data set(s) to determine a grayscale value thatrepresents a fluid flow through the sample 204.

In some embodiments, one or more time stamps (e.g., a scanning time) maybe associated with the images acquired by the imaging device 222. Thetime stamps may be used to generate a four-dimensional data setassociated with a fluid flow in the sample 204. The four-dimensionaldata set may be obtained by generating a three-dimensional data setbased on the images acquired by the imaging device 222 and applying thetime stamps to the three-dimensional data set.

In some embodiments, one or more radiographs may be acquired by theimaging device 222. A radiograph may represent a two-dimensionalprojection as interpreted by a detector of the imaging device 222. Athree-dimensional reconstruction may be generated based on a synthesisof a plurality of radiographs. A four-dimensional reconstruction may begenerated based on an application of the time stamps to thethree-dimensional reconstruction.

The systems 100 and 200 are illustrative. In some embodiments, one ormore of the components or devices may be optional. In some embodiments,the components/devices may be arranged in a manner that is differentfrom what is shown in FIGS. 10 and 11. In some embodiments, additionalcomponents or devices not shown may be included. For example, inembodiments where the system 100 or the system 200 is included as partof one or more networks, one or more switches, routers, and the like maybe included. One or more portions of the system 100 or the system 200may be included in a particular computing device, such as a server, apersonal computer, a laptop, a mobile device (e.g., a smartphone), etc.

As described above, the systems 100 and 200 may be used to obtain agrayscale value representative of a fluid flow in the sample 204.Referring to FIGS. 12A-3E (collectively referred to as FIG. 12) a flowchart of a method 300 is illustrated for obtaining such a grayscalevalue. The method 300 may be executed in conjunction with the system200, or a portion thereof.

In block 302, a data set may be obtained based on a plurality of imagesacquired by, e.g., the imaging device 222 of FIG. 11. The data setobtained in block 302 may by a four-dimensional data set/reconstruction.

In block 306, an estimate is obtained regarding a grayscale value thatis representative of the fluid flow. The estimate may be based on a userinput to the system 200 of FIG. 11.

In block 310, a theoretical (volumetric) flow rate of the fluid isobtained. The theoretical flow rate may be based on a user input to thesystem 200 of FIG. 11.

In block 314, a “previous grayscale variable” may be defined. As part ofblock 314, the previous grayscale variable may be initialized set to theestimate of the grayscale value obtained in block 306.

In block 318, a “current grayscale variable” may be defined. As part ofblock 318, the current grayscale variable may be initialized/set to theestimate of the grayscale value obtained in block 306.

In block 322, an “adjustment variable” may be defined. As part of block322, the adjustment variable may be initialized/set equal to an“adjustment value”. For reasons that will become more apparent to askilled artisan in view of the disclosure provided below, the adjustmentvalue may be selected based on a degree of accuracy that is required andmay be representative of a time it takes for the method 300 to convergeto a final grayscale value representative of the fluid flow.

One skilled in the art will appreciate that the labels applied to thevariables in connection with the blocks 314-322 are merely illustrativeand the naming convention used is merely intended to signify the natureor use of the variables. One skilled in the art would appreciate that amore generic naming convention could be used (e.g., first variable,second variable, etc.) without departing from this disclosure.

In connection with block 326, a number of sub-blocks/operations may beiteratively performed to arrive at, or converge to, a final grayscalevalue representative of the fluid or fluid flow. Block 326 is describedin further detail below in connection with FIGS. 12B-12E.

In block 326-a (see FIG. 12B), a volume may be calculated for the dataset of block 302 based on the current grayscale variable. As part ofblock 326-a, a determination may be made regarding a volume of what isintended to be the fluid as a function of length (e.g., radial axis) forevery data set/reconstruction of block 302. This may be done by addingup the volume of each voxel in each layer of the reconstruction whosegrayscale value is between the current grayscale variable and an upperbound whose value is fixed relative to the current grayscale variable.As an illustrative example, if the current grayscale variable has avalue of 1.34, and an upper bound offset is equal to 2.20, the upperbound may be equal to 1.34+2.20=3.54.

In block 326-b, a flow rate may be calculated based on the volumecalculated in block 326-a. As part of block 326-b, a linear regressionmay be used to calculate the flow rate. The flow rate may be based on aderivative of a curve formed with: (A) volume as a dependent variable,and (B) imaging (e.g., scanning) time as an independent variable.

In block 326-c, an error may be calculated as a difference between thecalculated flow rate of block 326-b and the theoretical flow rate ofblock 310. The error calculation of block 326-c may be conducted on anabsolute value basis, such that the sign/polarity in the error may bedisregarded.

In block 326-d, a comparison may be made to determine whether the errorcalculated in block 326-c is less than a threshold. The threshold may bebased on, or correspond to, the error calculated in block 326-c during aprevious iteration associated with block 326. If the error is less thanthe threshold, flow may proceed from block 326-d to block 326-e (seeFIG. 12C). Otherwise (e.g., the error is greater than or equal to thethreshold), flow may proceed from block 326-d to block 326-f (see FIG.12D).

In block 326-e (see FIG. 12C), the previous grayscale variable may beset equal to the current grayscale variable.

In block 326-g, the current grayscale variable may be modified based onthe adjustment variable. For example, as part of block 326-g theadjustment variable may be subtracted from the current grayscalevariable to generate an updated current grayscale variable. Flow mayproceed from block 326-g to block 326-a.

In block 326-f (see FIG. 12D), a comparison may be made to determinewhether the adjustment variable is less than a (second) threshold. Thisthreshold may be based on a resolution associated with the system (e.g.,system 200) that is used. The threshold may be based on a user input.The threshold may serve as a factor in the time it takes for the method300 to converge to a final grayscale value representative of the fluidflow; a smaller value of the threshold (representative of a fineresolution) may result in a longer convergence time relative to a largervalue (representative of a coarse resolution), all other things beingequal. The threshold may correspond to a predetermined value associatedwith an accuracy resolution. If it is determined in block 326-f that theadjustment variable is less than the threshold, flow may proceed fromblock 326-f to block 326-h. Otherwise (e.g., the adjustment variable isgreater than or equal to the threshold), flow may proceed from block326-f to block 326-i (see FIG. 12E).

In block 326-h, the iteration associated with block 326 may end. Flowmay proceed from block 326-h to block 330 (see FIG. 12A).

In block 326-i (see FIG. 12E), the previous grayscale variable may beset equal to the current grayscale variable.

In block 326-j, the adjustment variable may be modified by reducing thevalue of the adjustment variable. For example, the adjustment variablemay be reduced in half in block 326-j.

In block 326-k, the current grayscale variable may be modified based onthe adjustment variable. For example, as part of block 326-k theadjustment variable may be added to the current grayscale variable togenerate an updated current grayscale variable. Flow may proceed fromblock 326-k to block 326-a.

In block 330 (see FIG. 12A), the previous grayscale variable may beprovided as a representation of the fluid or fluid flow. The method 300may end following block 330.

While some of the parameters described above in conjunction with themethod 300 were described in terms of volume, the parameters may beexpressed in other terms (potentially in lieu of expressing theparameters in terms of volume). For example, at least some of theparameters may analogously be expressed in terms of mass via one or morefactors that may be used to convert between volume and mass, asdescribed further below.

In some embodiments, a calibration may be performed in connection withthe fixture 202. For example, and referring to FIG. 13, a fixture 402(which may correspond to the fixture 202 of FIG. 11) may be configuredto retain the sample 204 and a reference sample 404 (in FIG. 13, detailsof the retaining mechanism 206, the bore 208, and the wrapper 212 areomitted, with the understanding that the same or analogous componentsmay be applied to the sample 204 and/or the reference sample 404 in thefixture 402 of FIG. 13). The reference sample 404 may be used tocalibrate the grayscale value due to the fluid in the reference sample404 being the same as that being introduced into the sample 204, as wellas the mass or volume of the fluid being predetermined/known.

If the reference sample 404 is placed/located out of plane with respectto the sample 204, the likelihood of any other materials with the samegrayscale value appearing in-plane with the reference sample 404 issufficiently low in relation to any potential impact on accuracy (asidefrom an insignificant amount of noise that may be present). Therefore,if a correct grayscale value is chosen, volume statistics calculatedbetween the planes containing the reference sample 404 may proveaccurate.

Referring now to FIG. 14, a flow chart of a method 500 is shown. Themethod 500 may be executed to obtain a grayscale value representative ofa fluid or fluid flow. The method 500 may be similar to, or incorporateaspects of, the method 300 described above. Aspects of the method 300and the method 500 may be combined with one another in some embodiments.The method 500 may be executed in conjunction with the system 200 ofFIG. 11, or a portion thereof. The method 500 may be executed inconjunction with the fixture 402 of FIG. 13.

In block 502, a data set/reconstruction (e.g., block 302), an estimateof a grayscale value (e.g., block 306), a location of a reference sample(e.g., the sample 404), and a specification of the actual mass or volumeof the reference sample may be obtained. The location of the referencesample may be specified in terms of one or more planes (e.g., twoplanes). As part of block 502, an adjustment variable may beobtained/set, similar to block 322. Similarly, a current grayscalevariable may be obtained/set, similar to block 318.

In block 506, masses or volumes may be calculated for the data set ofblock 502 based on the current grayscale variable where the referencesample is located. As part of block 506, a volume may be converted to amass by multiplying the volume by the fluid's density. Block 506 may beanalogous, or similar, to blocks 326-a and 326-b. As part of block 506,one or more filtration or averaging techniques (e.g., root-mean-square(RMS)) may be applied.

In block 510, an error may be calculated as a difference between the(average) mass/volume calculated in block 506 and the actual referencesample mass/volume obtained in block 502. Block 510 may be analogous, orsimilar, to block 326-c.

In block 514, the error calculated in block 510 may be compared to athreshold (e.g., the error calculated in block 510 during a previousiteration of the method 500, which may be stored in a “previous error”variable). If the error of block 510 is less than the threshold, flowmay proceed from block 514 to block 518. Otherwise, flow may proceedfrom block 514 to block 522. Block 514 may be analogous, or similar, toblock 326-d.

In block 518, the current grayscale variable may be stored/saved (into aprevious grayscale variable) and then the current grayscale variable maybe modified using the adjustment variable. Block 518 may be analogous,or similar, to blocks 326-e and 326-g. Flow may proceed from block 518to block 506.

In block 522, a determination may be made whether the adjustmentvariable is less than a (second) threshold. Block 522 may be analogous,or similar, to block 326-f. If the adjustment variable is less than thethreshold, flow may proceed from block 522 to block 526 (and anyiteration in connection with the blocks 506-526 and 530 may be ended ina manner similar to block 326-h). Otherwise, flow may proceed from block522 to block 530.

In block 530, the grayscale value may be stored/saved (into the previousgrayscale variable) and then the current grayscale variable may bemodified on the basis of a modified value for the adjustment variable.Block 530 may be analogous, or similar, to blocks 326-i, 326-j, and326-k. Flow may proceed from block 530 to block 506.

In block 526, the saved/stored (e.g., previous) grayscale value (asreflected in the previous grayscale variable) may be selected torepresent the fluid or fluid flow. Block 526 may be analogous, orsimilar, to block 330.

As described herein, the methodological acts and processes may be tiedto particular machines or apparatuses. For example, one or morecomputers may include one or more processors and memory storinginstructions, that when executed, perform the methodological acts andprocesses described herein. Furthermore, the methodological acts andprocesses described herein may perform a variety of functions includingtransforming an article (e.g., a data set) into a different state orthing (e.g., a grayscale value representative of a fluid flow in asample). In some embodiments, the transformation may take place inaccordance with a predefined algorithm or formula.

While some of the examples described herein related to personal careproducts, one skilled in the art would appreciate that aspects of thedisclosure may be applied in connection with other types of samples.

Technical effects and benefits of this disclosure include an ability toaccurately and quickly characterize a fluid flow applied to a sample asthe fluid enters and flows through the sample. This characterization maybe made available on a substantially real-time basis, providing insightinto the progression of the fluid through the sample.

Aspects of the disclosure have been described in terms of illustrativeembodiments thereof. Numerous other embodiments, modifications, andvariations within the scope and spirit of the appended claims will occurto persons of ordinary skill in the art from a review of thisdisclosure. For example, one of ordinary skill in the art willappreciate that the steps described in conjunction with the illustrativefigures may be performed in other than the recited order, and that oneor more steps illustrated may be optional in accordance with aspects ofthe disclosure. One or more features described in connection with afirst embodiment may be combined with one or more features of one ormore additional embodiments.

What is claimed is:
 1. An apparatus configured to represent fluidassociated with a personal care product, the system comprising: a sampleof said personal care product; a fluid source containing a fluid; asyringe pump operatively connected to said fluid source, said syringepump controlling fluid flow; a line operatively connected to said fluidsource, said line having a line end, said line and said line endcomprising a low density material having a density sufficiently distinctfrom said sample; a platform movable about at least one axis, a fixturehaving an upper region, a middle region and a lower region, said fixturecomprising a radiographically transparent material, said fixture furthercomprising: a bore positioned within said fixture to receive said line;a first arm defining an opening in communication with said bore, saidopening permitting access to an interior volume of said fixture; saidfirst arm being hingedly connected to said fixture thereby permittingsaid first aria to move about an axis thereby enlarging said opening andrevealing said interior volume; and a wrapper positioned within saidfixture, said wrapper having an opening at a first end in communicationwith said line end, said wrapper substantially encompassing said samplesuch that fluid entering said wrapper through said line end issubstantially contained within said wrapper thereby creating a barrierbetween said sample and a surface defining said interior volume, saidwrapper comprising a low-density material that is sufficiently distinctfrom said sample; wherein said fixture exerts a force of between about0.1 psi and 5.0 psi.
 2. The apparatus of claim 1, wherein said fixturefurther comprises a second arm, said second arm being hingedly connectedto said fixture thereby permitting said second arm to move about asecond axis thereby enlarging said opening and revealing said interiorvolume.
 3. The apparatus of claim 1, wherein said fixture furthercomprises a retaining mechanism to assist in holding said personal careproduct.
 4. The apparatus of claim 1, wherein said fluid is one ofwater, saline, menses, blood, synthetic menses, glycerin, andcombinations thereof.
 5. The apparatus of claim 1, wherein said fixtureis at least partially visually transparent.
 6. An apparatus configuredto represent fluid associated with a personal care product, the systemcomprising: a sample of said personal care product; a fluid sourcecontaining a fluid; a syringe pump operatively connected to said fluidsource, said syringe pump controlling fluid flow; a line operativelyconnected to said fluid source, said line having a line end, said lineand said line end comprising a low density material other than metalhaving a density sufficiently distinct from said sample; a platformmovable about at least one axis, a fixture comprising a radiographicallytransparent material, said fixture further comprising: a first regionconnectable to said platform; a second region connectable to said firstregion, said second region simulating a second region of said humanbody, said second region having at least one contoured surface uponwhich to position said sample; a third region connectable to said secondregion; wherein said first region and said third region simulate anadditional region of said human body and/or support said second region.7. The apparatus of claim 6, wherein said second region furthercomprises a barrier that provides a barrier between said sample and asaid contoured surface, said barrier comprising a low-density materialthat is sufficiently distinct from said sample.
 8. The apparatus ofclaim 6, wherein said fixture exerts a force of between about 0.25 psiand 5.0 psi.